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A Study of NeoRecormon (Epoetin Beta) in Anemic Patients With Chronic Hepatitis C.

NCT00560274 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 190

Last updated 2016-02-02

No results posted yet for this study

Summary

This single arm study will assess the safety of NeoRecormon in the correction of anemia in patients with chronic hepatitis C who are being treated with Pegylated interferon + ribavirin combination therapy. Patients will receive NeoRecormon at a starting dose of 30,000 IU s.c. which will be adjusted as required to maintain a target Hb of 11-13g/dL. The anticipated time on study treatment is 1 year, and the target sample size is 100-500 individuals.

Conditions

Interventions

DRUG

Pegasys

As prescribed

DRUG

Ribavirin

As prescribed

DRUG

epoetin beta [NeoRecormon]

30,000 IU sc/week (starting dose)

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2011-11-30
Completion
2011-11-30

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00560274 on ClinicalTrials.gov